Washing donor blood with cell salvage machines

Apologies if this has been asked before. An interesting question from a student - if clinical staff are worried about increased potassium levels etc in donor red cell units and thus wash them through the cell saver prior to transfusion is this classed as processing units and therefore needing a specific license. I wasnít so sure as it isnít something Iíve come across before hence this post.

Normally use of a cell salvage process is unregulated by the BSQR, but this would be the first time I have heard of a blood component being washed in a cell salvage prior to transfusion. I will highlight this to an inspector for a response.

You will appreciate that since this original post our GMP inspectors have had more pressing matters to deal with, so in lieu of an official answer, I would go with my original answer and say that using a blood component in the way described would be classed as a processing step and would require that site to have a Blood Establishment Authorisation that specifically mandates that process. So, another way of saying it would be that cell salvage machines should never be used to process a blood collection.

As the question was theoretical, I feel confident to say that, but if I'm wrong I will let you know here.

Hi MJWL,
It would be interesting to know the hypothetical scenario we are talking about-what is the reason for the patient requiring blood with a lower K+ level?

Rashmi - there is no hypothetical scenario. We had a student who asked the question, who was writing up a piece on the BSQR and clinical practice for their portfolio. This is what I like about having students, sometimes the ďteachingĒ is a two way thing as they help us keep our own minds fresh.

Over in Germany they have published some work on washing donor blood through the cell salvage machine in their ED Resus. Main aim was to remove K+ and other contaminants, including haemolysis, but there is actually more haemolysis caused by the cell salvage process than that in a donor unit!
In critical scenerios I would be concerned about adding in additional delay, in obtaining a maching, priming it, spiking unit, sampling....etc, but their reports stated no impact on provision. It's not something that the UK is undertaking.